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New heart valve registry aims to improve safety and outcomes

NCT ID NCT07343674

Disease control Sponsor: Portuguese Association of Interventional Cardiology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This registry is following 500 adults in Portugal who have severe aortic stenosis and are getting a new type of heart valve replacement called the Medtronic Evolut FX+ TAVI system. The goal is to see if using a standardized procedure makes the treatment safer and more effective. Participants will be checked during their hospital stay, at 30 days, and at one year to track recovery, valve function, and any complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medtronic Evolut™ FX+ TAVI System (a device for replacing the aortic valve without open-heart surgery)
What this could lead to
If successful, this could help standardize the TAVI procedure to improve safety and reduce complications like the need for a pacemaker.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove cause and effect. Risks include procedural complications, need for a pacemaker, or valve problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes patients with severe, symptomatic AS with indication for TAVI, who meet the criteria for use of the Medtronic EvolutTM FX+ System in accordance with IFU and local regulations.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects more than 18 years old, able to provide an Informed Consent: * Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause; * Subjects provided written Informed Consent as approved by the Ethics Committee (EC); Exclusion Criteria: * Subjects with pre-existing surgical bioprosthetic aortic valve; * Hepatic insufficiency (Child-Pugh Class B or C); * Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU); * Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system; * Subjects are currently participating in another clinical investigation that may confound the results of this Registry; * Subjects have an expected survival less than one year.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe symptomatic aortic stenosis (defined as new york heart association (NYHA) class ≥ ii)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospitais da Universidade de Coimbra

    RECRUITING

    Coimbra, Coimbra District, 3004-561, Portugal

  • Hospital CUF Tejo

    RECRUITING

    Lisbon, Lisbon District, 1350-352, Portugal

  • Hospital Dr. Nélio Mendonça

    NOT_YET_RECRUITING

    Funchal, Madeira, 9004-514, Portugal

  • Hospital Eduardo Santos Silva

    NOT_YET_RECRUITING

    Vila Nova de Gaia, Vila Nova de Gaia, 4434-502, Portugal

  • Hospital Lusíadas Lisboa

    NOT_YET_RECRUITING

    Lisbon, Lisbon District, 1500-458, Portugal

  • Hospital Santa Maria

    RECRUITING

    Lisbon, Lisbon District, 1649-035, Portugal

  • Hospital Santa Marta

    RECRUITING

    Lisbon, Lisbon District, 2855-697, Portugal

  • Hospital Universitário de São João

    RECRUITING

    Porto, Porto District, 4200-319, Portugal

  • Hospital da Luz Coimbra

    NOT_YET_RECRUITING

    Coimbra, Coimbra District, 3020-479, Portugal

  • Hospital da Luz Lisboa

    NOT_YET_RECRUITING

    Lisbon, Lisbon District, 1500-650, Portugal

  • Hospital de Santa Cruz

    RECRUITING

    Lisbon, Lisbon District, 1449-005, Portugal

  • Hospital do Espírito Santo de Évora

    NOT_YET_RECRUITING

    Evora, Évora District, 7000-811, Portugal